Can neoadjuvant chemoradiotherapy be omitted in cT2N+ and cT3 mid-rectal cancer: Protocol for a prospective, observational, cohort study (CANO)

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dc.authorid0000-0002-1874-947X
dc.authorid0000-0002-2282-7207
dc.authorid0000-0001-7040-4228
dc.authorid0000-0002-4878-0873
dc.authorid0000-0003-2946-9569
dc.authorid0000-0002-8257-5881
dc.contributor.authorKarakayalı, Feza
dc.contributor.authorArslan, Çiğdem
dc.contributor.authorBisgin, Tayfun
dc.contributor.authorErenler Bayraktar, İlknur
dc.contributor.authorBayraktar, Onur
dc.contributor.authorCanda, Aras Emre
dc.date.accessioned2025-11-22T10:44:09Z
dc.date.available2025-11-22T10:44:09Z
dc.date.issued2025
dc.departmentFakülteler, Tıp Fakültesi, Cerrahi Tıp Bilimleri Bölümü, Genel Cerrahi Ana Bilim Dalı
dc.description.abstractBackground Neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME) is the standard treatment for locally advanced rectal cancer. However, nCRT is associ ated with significant morbidity, impacting patients’ quality of life. Recent advancements in MRI-based risk stratification have raised the possibility of omitting nCRT in selected patients without compromising oncologic outcomes. This study aims to evaluate whether upfront TME alone achieves similar 3-year disease-free survival compared to the standard approach of nCRT followed by TME in patients with cT2N+ and cT3Nx mid-rectal cancer without MRI-based high-risk features regarding local recurrence. Methods The CANO trial is a prospective, multicenter, observational cohort study involving 436 patients across Türkiye. Eligible patients will be classified into two groups: those undergoing direct TME and those receiving nCRT followed by TME. The primary endpoint is 3-year disease-free survival (DFS), with secondary outcomes including 5-year DFS, overall survival, local recurrence rates, and quality of life assessments using validated questionnaires. Data will be prospectively collected and monitored by the steering committee with predefined interim analyses. Discussion The CANO trial addresses the ongoing debate regarding selective omission of nCRT in low-risk mid-rectal cancer. By leveraging MRI-based risk stratification and PLOS One | https://doi.org/10.1371/journal.pone.0321819 November 5, 2025 2 / 11 a collaborative national network, the study aims to provide high-quality evidence supporting a more personalized treatment approach. The findings have the potential to reduce treatment-related morbidity without compromising oncologic safety, contrib uting to the refinement of current guidelines.
dc.description.sponsorshipThe Turkish Society of Colon and Rectal Surgery (TSCRS) is the sponsor of the study and covers all the expenses. These include the salary of the secretary employed for data collection, the costs of the server where the database is stored, and the expenses related to the website. TSCRS has also stated that it will cover any future expenses that may arise. The funder has no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This statement was included in the manuscript. Türk Kolon ve Rektum Cerrahisi Derneği (TKSRD), çalışmanın sponsoru olup tüm masrafları karşılamaktadır. Bu masraflar, veri toplama için istihdam edilen sekreterin maaşını, veritabanının depolandığı sunucunun maliyetlerini ve web sitesiyle ilgili masrafları içermektedir. TKSRD ayrıca, ileride doğabilecek tüm masrafları karşılayacağını belirtmiştir. Fon sağlayıcının çalışma tasarımı, veri toplama ve analizi, yayın kararı veya makalenin hazırlanmasında hiçbir rolü yoktur. Bu beyan, makalede yer almaktadır.
dc.identifier.citationKarakayali, F., Arslan, C., Bisgin, T., Erenler Bayraktar, İ., Bayraktar, O., & Canda, A. E. (2025) Can neoadjuvant chemoradiotherapy be omitted in cT2N+ and cT3 mid-rectal cancer: Protocol for a prospective, observational, cohort study (CANO). Plos One, 20(11), pp. 1-11. https://doi.org/10.1371/journal.pone.0321819
dc.identifier.doi10.1371/journal.pone.0321819
dc.identifier.endpage11
dc.identifier.issn1932-6203
dc.identifier.issue11
dc.identifier.pmidPMID: 41191581
dc.identifier.scopusqualityQ1
dc.identifier.startpage1
dc.identifier.urihttps://doi.org/10.1371/journal.pone.0321819
dc.identifier.urihttps://hdl.handle.net/20.500.13055/1199
dc.identifier.volume20
dc.identifier.wosqualityQ2
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.indekslendigikaynak.otherSCI-E - Science Citation Index Expanded
dc.institutionauthorArslan, Çiğdem
dc.institutionauthorid0000-0002-2282-7207
dc.language.isoen
dc.publisherPublic Library of Science
dc.relation.ispartofPlos One
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.titleCan neoadjuvant chemoradiotherapy be omitted in cT2N+ and cT3 mid-rectal cancer: Protocol for a prospective, observational, cohort study (CANO)
dc.typeArticle
dspace.entity.typePublication

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